Oral Insulin

Published on 22 Nov, 2013

Diabetes is a type of metabolic disorder caused by an insulin imbalance in the body either due to insufficient production of insulin by the pancreas or due to body cells not responding to the insulin that is produced. This leads to high blood sugar levels that, in turn, result in polyuria, polydipsia and polyphagia.

Diabetes is controlled using insulin with or without a combination of oral hypoglycaemic agents such as Metformin. Insulin is currently administered into the body via a subcutaneous or an intramuscular injection. These delivery routes are non-compliant with patients. In addition, the parenteral insulin targets peripheral tissues rather than the liver which disturbs the normal dynamics of endogenous insulin release. As a result, research was undertaken in oral administration as a route for insulin delivery. The research is in the experimental stage without any success due to stability problems of insulin in the gastrointestinal tract on oral administration.

Figure 1: Filing Trend

Oral Insulin Patent Filing Trend

Source: (Aranca analysis based on Thomson Innovation data)

The filing trend indicates more or less equal number of patents filed in the last five years. The trend suggests research on oral insulin is set to gather momentum as several pharmaceutical players would yearn for a successful product that can overpower the parenteral insulin market.

Figure 2: Origin Of Invention & Jurisdiction Spread

Origin of Invention Oral Insulin

Source: (Aranca analysis based on Thomson Innovation data)

Diabetes has become a worldwide epidemic due to lifestyle changes. The number of people suffering from diabetes is set to rise from 285 million in 2010 to 439 million by 2030. The highest prevalence has been observed in North America, Europe (mainly Germany and the UK), China, India and Japan. Consumption of insulin is high in these countries as it is the most preferred treatment modality. Due to the challenges of parenteral insulin, success of oral insulin will be a major breakthrough for diabetes. This could result in significant research and protection of innovation in oral insulin across lucrative markets such as the US, China, Japan, Europe and India by pharmaceutical firms.

Figure 3: Competitive Landscape

Oral Insulin Top Assignee

Source: (Aranca analysis based on Thomson Innovation data)

Large pharmaceutical players active in the diabetes sphere account for the most number of patents filed in oral insulin technology. Among these, Boehringer Ingelheim is the leader. Some molecules researched by these companies are under clinical phase trials. Also, some big firms invest in research initiated by speciality companies such as the partnership between Sanofi Aventis and Wellstat Therapeutics for oral insulin sensitizer PN2034.

Most players undertake research to address issues associated with earlier failures of oral insulin, such as reduced bioavailability, stability problems in the gastrointestinal tract and storage stability, in clinical trials. These issues are mainly addressed by insulin modification by acylating the insulin protein or modifying the formulation to render it orally compatible.